FDA Announces Recalls Of Trachea Tube And Catheter Devices

Two companies have recalled a series of tracheal tubes that may kink when inserted into a patient’s throat and a catheter guidewire with coating that my flake off in a patient’s blood vessels. The U.S. Food and Drug Administration (FDA) said Acme Monaco Corp. has recalled its .035×150 3MMJ TCFC guidewires, which are designed to fit inside a catheter for the purpose of directing the catheter through a blood vessel. The guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries Inc., the FDA said.

There is a risk of the guidewire’s coating flaking off the wire, which according to the FDA could result in “serious adverse health consequences.” The recall is classified as the most serious “class 1” variety, defined as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The FDA said Teleflex Medical Inc. has voluntarily recalled an undisclosed number of the ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction devices. That recall is also of the class 1 variety.

The affected products were manufactured from December 2009 through November 2013 and distributed from March 2010 through December 2013, and are inserted into a patient’s windpipe through the nose or mouth and used to maintain an open airway. “The affected tracheal tube may kink during patient use. If a tracheal tube kinks, it can deprive the patient of adequate ventilation, causing serious patient injury including hypoxic injury and/or anoxia, and death,” the FDA said. Acme Monaco and Teleflex did not immediately respond to requests for comment Tuesday.

In January, the FDA said Tandem Diabetes Care Inc. was recalling some insulin cartridges that were at risk for leaking. A cartridge leak could potentially result in the delivery of too much or too little insulin, which could lead to unexpected high or low blood glucose levels. Too much insulin can result in severe low blood sugar and too little insulin can lead to severe high blood sugar, both of which can lead to serious injury or death, the FDA said. And earlier that same month, Abbott Diabetes Care Inc. recalled some blood glucose tests that may have delivered erroneously low blood glucose results.

A false test result of low blood glucose result can lead to failure to diagnose and appropriately treat high blood sugar or inappropriate treatment, and treatment of an erroneously low glucose result may lead to too much carbohydrate intake or insulin under dose, and could result in hyperglycemia and other serious adverse health consequences, including death.